Journal of Pharmacovigilance

Abstract

Some Specific Regulatory Aspects and Nuances of Drug Products Localization in the Russian Federation

Anna Soltitskaya

Some important things you should know about drug products localization regulations in Russia. Brief overview of the main local regulations and factual law-enforcement practices that have an impact on your drug products localization projects. According to the Russian Government Decree, ? 1289 dated by Nov. 30, 2015 “On limitations of drug products manufactured by foreign manufacturers as participants of Government Procurement” (so called rule “The third wheel”): if two applications at least for the Russian products are submitted, so any third application from some foreign manufacturer (not the Russian product) cannot be accepted. The Russian Federal Law 61 FZ “On drugs circulation” is the basic general legislation Act that regulates Drugs (DP & API) circulation (research & developing, clinical trials, manufacturing, expertise and registration, supply, sale, marketing etc.)